1. BUSINESS SENSITIVE 1 Copyright © 2009 by James E. Dvorsky, Battelle Medical Device Solutions Compliance Engineering Jim Dvorsky Battelle Medical Device Solutions

2. BUSINESS SENSITIVE 2 Copyright © 2009 by James E. Dvorsky, Battelle Medical Device Solutions Introduction to Compliance Engineering What is Compliance Engineering? What does it mean to have a compliant product? Why is Compliance Engineering important? When and where does it begin? When and where does it end? How is product compliance achieved? Who is responsible for product compliance? What role can I play in Compliance Engineering?

3. BUSINESS SENSITIVE 3 Copyright © 2009 by James E. Dvorsky, Battelle Medical Device Solutions What is Compliance Engineering? Compliance Engineering is designing and developing a product to meet a set of safety standards specific to that class of products. A compliant product is one that has undergone an evaluation and meets the stipulations set forth by the market. The evaluation may be performed by product manufacturer… –CE Marking, Witnessed testing …Or may be performed by an independent party. –NRTL, Certifying Body

4. BUSINESS SENSITIVE 4 Copyright © 2009 by James E. Dvorsky, Battelle Medical Device Solutions Product Safety Requirements Where do product safety requirements come from? Who oversees the requirements and the products intended to conform to them? Can anyone perform a product evaluation? Who or what constitutes an independent evaluator? Can’t a product just get a safety mark and be done with this process? Is electromagnetic compatibility (EMC) different from product safety or just a part of it?

5. BUSINESS SENSITIVE 5 Copyright © 2009 by James E. Dvorsky, Battelle Medical Device Solutions Alphabet Soup AAMIANSIBSICB CCCCECEICISPR CSAEMCEMIESD ETLEUFCCFDA GHTFGSIECISO ITSIVDJSALVD MDDNARTENEMKONOM NRTLOSHAROHSSEMKO TUVULVDEWEEE

6. BUSINESS SENSITIVE 6 Copyright © 2009 by James E. Dvorsky, Battelle Medical Device Solutions Standards Writing Organizations AAMIANSIBSICB CCCCECEICISPR CSAEMCEMIESD ETLEUFCCFDA GHTFGSIECISO ITSIVDJSALVD MDDNARTENEMKONOM NRTLOSHAROHSSEMKO TUVULVDEWEEE

7. BUSINESS SENSITIVE 7 Copyright © 2009 by James E. Dvorsky, Battelle Medical Device Solutions Standards Incorporating Organizations AAMIANSIBSICB CCCCECEICISPR CSAEMCEMIESD ETLEUFCCFDA GHTFGSIECISO ITSIVDJSALVD MDDNARTENEMKONOM NRTLOSHAROHSSEMKO TUVULVDEWEEE

8. BUSINESS SENSITIVE 8 Copyright © 2009 by James E. Dvorsky, Battelle Medical Device Solutions Standards Acceptance and Renaming An independent (often international) organization generates a standard based on the consensus of the members participating on the committee –IEC 61010-1 Members of the European Economic Community accept the standard –EN 61010-1 Individual countries in EEC accept the standard, with deviations specific to their country –BS EN 61010-1 –DS EN 61010-1 –TSE 61010-1 –GOST-R 61010-1 Other countries adopt standard, with deviations –UL 61010-1 –CSA-C22.2 No. 61010-1 –JIS C 1010-1

9. BUSINESS SENSITIVE 9 Copyright © 2009 by James E. Dvorsky, Battelle Medical Device Solutions Standards Testing Organizations AAMIANSIBSICB CCCCECEICISPR CSAEMCEMIESD ETLEUFCCFDA GHTFGSIECISO ITSIVDJSALVD MDDNARTENEMKONOM NRTLOSHAROHSSEMKO TUVULVDEWEEE

10. BUSINESS SENSITIVE 10 Copyright © 2009 by James E. Dvorsky, Battelle Medical Device Solutions Product Safety Marks AAMIANSIBSICB CCCCECEICISPR CSAEMCEMIESD ETLEUFCCFDA GHTFGSIECISO ITSIVDJSALVD MDDNARTENEMKONOM NRTLOSHAROHSSEMKO TUVULVDEWEEE

11. BUSINESS SENSITIVE 11 Copyright © 2009 by James E. Dvorsky, Battelle Medical Device Solutions But wait, there’s more… AAMIANSIBSICB CCCCECEICISPR CSAEMCEMIESD ETLEUFCCFDA GHTFGSIECISO ITSIVDJSALVD MDDNARTENEMKONOM NRTLOSHAROHSSEMKO TUVULVDEWEEE

12. BUSINESS SENSITIVE 12 Copyright © 2009 by James E. Dvorsky, Battelle Medical Device Solutions Why is Compliance Engineering Important? This question requires a two-part answer: 1.Product safety compliance, which may or may not include electromagnetic compatibility, is necessary for acceptance of the product into specific markets. 2.Designing the product with compliance in mind throughout the development process is a proven method of obtaining the desired outcome with maximum efficiency.

13. BUSINESS SENSITIVE 13 Copyright © 2009 by James E. Dvorsky, Battelle Medical Device Solutions When and Where does the Product Compliance Process Begin (and End)? It begins with the targeted end user –Determine where you plan to sell your product: specific countries or regions –Determine if you would like a product safety mark on the product and which one(s) –Decisions are Market-driven Compliance engineering takes place throughout product development Compliance process continues through manufacturing and product placement –On-site inspections –Customer feedback It ends at the end of life for product (device retirement)

14. BUSINESS SENSITIVE 14 Copyright © 2009 by James E. Dvorsky, Battelle Medical Device Solutions Facets of Product Compliance Protection of Operator –Electrical shock (hazardous voltages, currents) –Mechanical hazards (moving parts, pinch, impact) –Thermal hazards (hot surfaces, fire) –Radiation (ionizing, optical, acoustic, EM) Protection of Patient –Similar to protection of operator, but more stringent Protection of Environment –Electromagnetic interference (EMI)

15. BUSINESS SENSITIVE 15 Copyright © 2009 by James E. Dvorsky, Battelle Medical Device Solutions Facets of Product Compliance (con’t) Product Installation –Facility requirements –Instructions Operation of Product –User interface (ease of use, interpretation of displays, effectiveness of interface) –Alarm features (intensity, frequency content) –Instruction manual Product Maintenance –Operator-performed –Maintenance personnel –Training requirements Special precautions and circumstances –Unique to product

16. BUSINESS SENSITIVE 16 Copyright © 2009 by James E. Dvorsky, Battelle Medical Device Solutions Hierarchy of Product Standards General Safety Standard –Suited to family of products having similar operating environments or uses –Standard number has no dash number or “-1” Collateral Standard –Focuses on safety subject that is common to the family, but deserves more detailed attention –Standard number ends in -1-X, where X is specific to the subject Particular Standard –Focuses on a particular type of product within the family because special or unique attention is required –Standard number ends in -2-Y, where Y is specific to the sub-classification of products

17. BUSINESS SENSITIVE 17 Copyright © 2009 by James E. Dvorsky, Battelle Medical Device Solutions How is Product Compliance Achieved? Product Design –Always the primary approach to safety –Prescriptive requirements specified in the standards –Use of listed products within the scope of their intended use –Design must always be mindful of maintaining safety under normal (NC) and single-fault conditions (SFC) Product Labeling –Markings on product itself –Instructions on accompanying documents Risk assessment of product –Documentation supporting risk assessment and decision process Following guidelines provided by regulatory body –FDA

18. BUSINESS SENSITIVE 18 Copyright © 2009 by James E. Dvorsky, Battelle Medical Device Solutions Who is Responsible for Product Compliance? Short answer: everyone associated with the product! Long answer –Manufacturer is responsible for designing a compliant product –Independent evaluator stands behind the quality of the evaluation and results –Manufacturer maintains consistency in manufacturing –Owner of product safety mark stands behind the quality of the evaluation and results AND performs regular inspections –User (ultimate customer) operates device as intended and follows instructions –Manufacturer responds to feedback to modify product or remove it from the market

19. BUSINESS SENSITIVE 19 Copyright © 2009 by James E. Dvorsky, Battelle Medical Device Solutions What role can I play in Compliance Engineering? Know and utilize your Compliance Engineering experts Be product safety conscious Realize that Compliance Engineering is part of the product development process Know what you talking about; get educated Educate others

20. BUSINESS SENSITIVE 20 Copyright © 2009 by James E. Dvorsky, Battelle Medical Device Solutions “A man’s got to know his limitations.” Harry Callahan “Magnum Force” (1973)